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Pharmacosmos A/S

FDA Regulatory Profile

Pharmacosmos A/S has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Pharmacosmos A/S" and its spelling variant "Pharmacosmos".

Latest inspection: Sep 25, 2025 · VAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	7	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Pharmacosmos A/S's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	1	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

7 inspections from Mar 25, 2009 to Sep 25, 2025.

Date	Site	Product	Classification	FEI
Sep 25, 2025	Holbak, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807874
Oct 14, 2022	Holbak, Denmark	Veterinary	Voluntary Action Indicated (VAI)	3002807874
Sep 13, 2019	Holbak, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807874
May 18, 2018	Holbak, Denmark	Veterinary	Voluntary Action Indicated (VAI)	3002807874
Aug 26, 2016	Holbak, Denmark	Veterinary	Voluntary Action Indicated (VAI)	3002807874
Dec 20, 2013	Holbak, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807874
Mar 25, 2009	Holbak, Denmark	Veterinary	Voluntary Action Indicated (VAI)	3002807874

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002807874	Holbak, Denmark	7	Sep 25, 2025

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